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Devices Cardiology

 News Release - June 18, 2013

Promising Mid-Term Results From Thoracoscopic Ablation of Persistent Atrial Fibrillation Presented at Meeting of International Society for Minimally Invasive Cardiothoracic Surgery

Patients show three-year freedom from atrial fibrillation, anti-arrhythmic drugs

PRAGUE--(Healthcare Sales & Marketing Network)--A leading German cardiovascular heart center reported promising mid-term results for the surgical treatment of persistent atrial fibrillation (Afib) during last week’s International Society for Minimally Invasive Cardiothoracic Surgery (ISMICS) meeting being held in Prague, Czech Republic. At three-year follow-up, 80 percent of persistent Afib patients were free from Afib and off anti-arrhythmic medications using AtriCure’s Bipolar RF Ablation System. These results compare favorably with a more commonly performed, catheter-based approach. The team at Sana Heart Center in Stuttgart, Germany performed the beating heart thoracoscopic surgical procedures under the guidance of Professor Nicolas Doll, Chief of Cardiovascular Surgery at Sana.

Afib is an irregular heartbeat that affects up to 2 percent of the population worldwide. The risk of stroke is five times greater in patients suffering from this disease. Afib is responsible for 15-20 percent of all strokes and is associated with increased mortality, morbidity and a reduced quality of life.

Catheter ablation is a common treatment in patients with symptomatic Afib not responding to medications. However, mid-term results of more chronic forms of Afib even after repeat catheter ablation have been marginal. Surgical ablation is a promising, single procedure alternative being researched in advanced heart centers like Sana Heart Center.

“Catheter ablation is quite effective in less severe forms of Afib, but chronic Afib demands a more intensive approach in terms of making robust scars on the heart to thoroughly interrupt the electrical signals that cause the problem. We have demonstrated that this minimally invasive approach yields superior results in these challenging forms of Afib,” said Prof. Nicolas Doll, M.D., Director of the Sana Heart Center.

From 2009 to 2013 Stuttgart group enrolled 121 patients in the study, 25 percent of whom had failed at least two previous catheter ablation procedures. The objective of the study was to evaluate the efficacy of an endoscopic approach in performing a left atrial lesion set on the beating heart. Radiofrequency ablation was performed via a bilateral endoscopic ablation approach using small ports and a microscopic camera for visualization. Post procedure heart rhythms were evaluated using sophisticated monitoring protocols at 6, 12, 24 and 36 months to determine procedural success.

During the study, there were no deaths, no conversions to sternotomy and no early or late strokes. The data showed that 80 percent of patients were free from Afib three years after their procedures, and 80 percent were free from both Afib and anti-arrhythmic drugs three years after surgery. Quality of life improvements were shown to increase significantly from preoperative assessments.

“This new thoracoscopic approach to treat chronic Afib is a big step toward a less invasive treatment with excellent clinical and cosmetic results. We believe that working in collaboration with our electrophysiologists that the results can be improved further. However randomized trials are necessary to establish this approach as a standard of care,” said Dr. Doll.

For details on this study, please see ISMICS website

About AtriCure, Inc.

AtriCure, Inc. (ATRC) is a medical device company providing innovative atrial fibrillation (Afib) solutions designed to produce superior outcomes that reduce the economic and social burden of atrial fibrillation. AtriCure’s Synergy Ablation System is the first and only device approved for the treatment of persistent and longstanding persistent forms of Afib in patients undergoing certain open concomitant procedures. AtriCure’s ATriClip Left Atrial Appendage (LAA) exclusion device is the most widely implanted device for LAA management worldwide. The company believes cardiothoracic surgeons are adopting its ablation and LAA management devices for the treatment of Afib and reduction of Afib related complications such as stroke. Afib affects more than 5.5 million people worldwide.

The FDA has not cleared or approved certain AtriCure products for the treatment of Afib or a reduction in the risk of stroke. Synergy Ablation RF clamps are approved for the treatment of Afib. AtriCure reference number: MKT-1730A-G

Source: AtriCure

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